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510(k) K935154

DENTAURUM EXPANSION SCREWS by Dentauraum, Inc. — Product Code DYJ

K935154 is an FDA 510(k) premarket notification submitted by Dentauraum, Inc. for the device "DENTAURUM EXPANSION SCREWS". The FDA issued a decision of Substantially Equivalent on February 3, 1994. The device falls under product code DYJ (Retainer, Screw Expansion, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Dentauraum, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1994
Date Received
October 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retainer, Screw Expansion, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

Other clearances by Dentauraum, Inc.

  • K952867 — REMANIUM:GM 700, GM 380, GM 800, GFH (July 27, 1995)
  • K952866 — REMATITAN TITANIUM (July 27, 1995)
  • K952870 — REMANIUM: CS & G-SOFT (July 27, 1995)
  • K952865 — REMANIUM: 200,CS, 380, AND CD (July 26, 1995)
  • K952868 — DENTAURUM JACKET CROWN & ROOT POSTS (July 19, 1995)
  • K942667 — DENT-O-CRYL ORTHODONTIC ACRYLIC (February 13, 1995)
  • K942666 — ORTHALGENAT IMPRESSION MATERIAL (August 10, 1994)
  • K936151 — EXTRAORAL HEADGEAR (August 1, 1994)
  • K942668 — O-TRAY IMPRESSION TRAYS (July 22, 1994)
  • K942665 — ORTHOCENT: LIQUID AND POWDER (July 22, 1994)

Other clearances for product code DYJ

  • K970930 — BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE (April 23, 1997)
  • K925088 — EXPANSION SCREWS (May 22, 1993)
  • K912417 — MOLAR DISTALIZING ASSEMBLY (December 20, 1991)
  • K843705 — MANDIBULATOR JAW POSITIONER (November 14, 1984)

FDA data resources